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NCT06399757 | RECRUITING | Colorectal Cancer

A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
Sponsor:

Apollo Therapeutics Ltd

Brief Summary:

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).

Condition or disease

Colorectal Cancer

Cholangiocarcinoma

Appendiceal Adenocarcinoma

Pancreatic Adenocarcinoma

Gastric Adenocarcinoma

Endometrial Adenocarcinoma

Triple Negative Breast Cancer

Ovarian Cancer

Prostate Cancer

Intervention/treatment

APL-5125

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors
Actual Study Start Date : 2024-06-18
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 18 years or older
  • * Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.
  • * For Phase 1 sub-studies: Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer, Prostate Cancer
  • * Phase 2: Colorectal carcinoma
  • * No available standard of care therapy or participant is ineligible for standard of care therapy, except in CRC tumor type in which participant must have previously received all the following therapeutic agents
    • * fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
    • * an anti-VEGF therapy
    • * if wt-RAS (wt-KRAS and wt-NRAS), an anti-EGFR therapy
    • * Eastern Cooperative Oncology Group (ECOG) ≤1
    • * Body Weight ≥40 kg.
    • * Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse
    • * Male participants must be willing to use specific contraception and not plan to impregnate a female partner or donate sperm while on study
    • * Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial
    Exclusion Criteria
    • * Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically significant ventricular arrhythmias, symptomatic congestive heart failure, uncontrolled active infection, history of significant hemorrhage within 4 weeks of the first dose date, intestinal disease or major gastric surgery, arterial thrombosis within 6 months of screening
    • * Certain prior therapies such as: anti-cancer treatment within 2 weeks of Cycle 1 Day 1, prior radiotherapy within 14 days before screening, active anti-coagulation therapy, over the counter or prescription medications within 14 days or 5 half-lives prior to cycle 1 day 1, herbal medicines and supplements within 14 days
    • * Major surgery within 1 month of screening
    • * Hemoglobin \< 9.0 g/dL
    • * Absolute neutrophil count \< 1.5 x 10\^9/L
    • * Platelet count \< 100 x 10\^9/L
    • * Hepatic function
      • 1. Aspartate aminotransferase and/or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) (\>5 x ULN for subjects with liver metastases)
      • 2. Total bilirubin \>1.5 × ULN (except participants with Gilbert's syndrome).
      • 3. Albumin \< 3 g/dL
      • * Calculated or measured creatinine clearance of \<60 mL/minute calculated using the formula of Cockcroft and Gault (\[140 - Age\] × Mass \[kg\] / \[72 × serum creatinine mg/dL\]). Multiply result by 0.85 if female.
      • * Fridericia's corrected QT interval (QTcF) \>470 msec or a family history of Long QT Syndrome.
      • * Cardiac function: Echocardiogram (or MUGA) showing Left Ventricular Ejection Fraction (LVEF) \<45% at rest
      • * Infectious diseases: positive for HIV (unless controlled with active retroviral therapy), hepatitis B and hepatitis C
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors

Location Details

NCT06399757

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, California

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States, 92618

RECRUITING

United States, Florida

Florida Cancer Specialists & Research Institute

Sarasota, Florida, United States, 34232

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, North Carolina

Duke Cancer Institute

Durham, North Carolina, United States, 27710

RECRUITING

United States, North Carolina

Carolina BioOncology Institute

Huntersville, North Carolina, United States, 28078

RECRUITING

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

RECRUITING

United States, Texas

Mary Crowley Cancer Research

Dallas, Texas, United States, 75251

RECRUITING

United States, Texas

NEXT Oncology- San Antonio

San Antonio, Texas, United States, 78229